Primary Device ID | D7641000064561 |
NIH Device Record Key | a5425fe5-1299-48f6-b449-634a90f869fb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Intraoral Sensor Wallbox |
Version Model Number | 100006456 |
Company DUNS | 078613913 |
Company Name | SIRONA DENTAL, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | (877) 724-4254 |
customerserviceny@sirona.com | |
Phone | (877) 724-4254 |
customerserviceny@sirona.com | |
Phone | (877) 724-4254 |
customerserviceny@sirona.com | |
Phone | (877) 724-4254 |
customerserviceny@sirona.com | |
Phone | (877) 724-4254 |
customerserviceny@sirona.com | |
Phone | (877) 724-4254 |
customerserviceny@sirona.com | |
Phone | (877) 724-4254 |
customerserviceny@sirona.com | |
Phone | (877) 724-4254 |
customerserviceny@sirona.com | |
Phone | (877) 724-4254 |
customerserviceny@sirona.com | |
Phone | (877) 724-4254 |
customerserviceny@sirona.com | |
Phone | (877) 724-4254 |
customerserviceny@sirona.com | |
Phone | (877) 724-4254 |
customerserviceny@sirona.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D7641000064561 [Primary] |
MUH | System,X-Ray,Extraoral Source,Digital |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2022-12-09 |
Device Publish Date | 2018-05-10 |
D7641000064651 | Intraoral Sensor Wallbox Without Display |
D7641000064580 | Intraoral Sensor Wallbox Without Display |
D7641000064571 | Intraoral Sensor Wallbox Display Upgrade Kit |
D7641000064561 | Intraoral Sensor Wallbox With Display |
D7641000064510 | Intraoral Sensor Wallbox With Display |